The TearAD Study: Tear Biomarkers for Alzheimer's Disease (AD) Screening and Diagnosis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The goal of this observational longitudinal study is to investigates whether tear fluid is a non-invasive source of biomarkers for Alzheimer's disease. The main aim of the study is to evaluate diagnostic accuracy measures (sensitivity and specificity) of tear and retinal biomarkers to discriminate individuals with and without neurodegeneration. Tear fluid from participants will be collected non-invasively with Schirmer's strips, which is a small paper strip placed in the lower eye lid for a maximum of 5 minutes. Additionally, standard, ultra-wide field and cross-sectional retinal images will be obtained.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
View:

• Available CSF, PET, CT or MRI data to evaluate the presence/absence of neurodegeneration (preferably within 1 year of inclusion in this study)

• Absence of cognitive complaints or treatment and did not seek help for cognitive complaints in the past

• MMSE score 26-30 at baseline

• Age \> 50 years

• Available for follow-up (up to 24 months)

• Written informed consent obtained and documented

• Available CSF, PET, CT or MRI data to evaluate the presence/absence of neurodegeneration (preferably within 1 year of inclusion in this study)

• Available for follow-up (up to 24 months)

• Written informed consent obtained and documented

• Capable of giving informed consent themselves (MMSE score \> 17/30)

Locations
Other Locations
Netherlands
Amsterdam University Medical Center
RECRUITING
Amsterdam
Academic Hospital Maastricht
RECRUITING
Maastricht
Contact Information
Primary
Marlies Gijs, PhD
marlies.gijs@mumc.nl
+31 (0)43 3872241
Backup
Nienke van de Sande, MSc
nienke.van.de.sande@mumc.nl
+31 (0)43 3875345
Time Frame
Start Date: 2022-06-09
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 200
Treatments
With Neurodegeneration
Includes patients with mild cognitive impairment and dementia
Without Neurodegeneration
Includes healthy controls and patients with subjective cognitive decline
Related Therapeutic Areas
Sponsors
Leads: Maastricht University Medical Center

This content was sourced from clinicaltrials.gov